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REGULATORY ANALYSIS

for Amendments to 6 CCR 1009-2 The Infant Immunization Program And Immunization Of Students Attending School

Adopted by the Board of Health on November 18th, 2020

1. A description of the classes of persons affected by the proposed rule, including the classes that will bear the costs and the classes that will benefit from the proposed rule.

|Group of persons/entities Affected by the Proposed Rule |Size of the Group |Relationship to the Proposed |

| | |Rule |

| | |Select category: C/CLG/S/B |

|Approximately 2,150 public and private schools, approximately 2,100 licensed child | |C, CLG |

|cares, thousands of healthcare providers throughout the state, the Colorado Department | | |

|of Education, the Colorado Department of Human Services and 53 county, district or | | |

|municipal public health agencies (LPHAs) rely on the rule to maintain their own | | |

|businesses, agencies or operations. | | |

|Advocacy organizations such as Immunize Colorado, professional organizations such as | |S |

|the Colorado Chapter of the American Academy of Pediatrics or Colorado Academy of | | |

|Family Physicians, federal agencies such as the Centers for Disease Control and | | |

|Prevention, and health care providers. | | |

|Students enrolled in Colorado schools and, if under 18 years of age, their | |S, B |

|parents/guardians, and the public at large. | | |

While all are stakeholders, groups of persons/entities connect to the rule and the problem

being solved by the rule in different ways. To better understand those different relationships,

please use this relationship categorization key:

C = individuals/entities that implement or apply the rule.

CLG = local governments that must implement the rule in order to remain in compliance with the law.

S = individuals/entities that do not implement or apply the rule but are interested in others applying the rule.

B = the individuals that are ultimately served, including the customers of our customers. These individuals may benefit, be harmed by or be at-risk because of the standard communicated in the rule or the manner in which the rule is implemented.

2. To the extent practicable, a description of the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons.

Economic outcomes

Summarize the financial costs and benefits, include a description of costs that must be incurred, costs that may be incurred, any Department measures taken to reduce or eliminate these costs, any financial benefits.

The Department will incur minimal costs to implement this rule, including updating certificates of medical and nonmedical exemption, updating the online education module and updating the annual parent letter.

C and CLG: As the rule primarily makes changes to the process by which a parent or student claims a nonmedical exemption, there are no anticipated additional implementation costs to schools, providers or LPHAs. Further, the fiscal note for SB 20-163 did not identify costs for these groups.

S: None.

B: The purpose of immunization requirements for school entry is to protect students, staff, and the visiting public against vaccine-preventable diseases within schools and broader communities. The Department anticipates these rule changes will lead to higher vaccination rates in schools and, subsequently, the surrounding community and result in decreases in vaccine-preventable disease.

Tangibly, less vaccine-preventable disease means fewer sick kids and results in cost avoidance related to doctor visits, emergency department (ED) or hospitalization visits, missed school absences and missed work for parents/guardians. Per a March 2020 report from Children’s Hospital Colorado, 524 Colorado children were hospitalized and over 10,000 Colorado children had ED visits in 2018 due to vaccine-preventable diseases.

Parents and enrolled students of Colorado schools that submit a certificate of nonmedical exemption will now either have to include a signature from a healthcare provider licensed to administer immunizations or view the Department’s online education module prior to claiming a nonmedical exemption. Because parents and enrolled students can choose which way they secure a valid certificate of nonmedical exemption, there are no anticipated costs.

Non-economic outcomes

Summarize the anticipated favorable and non-favorable non-economic outcomes (short-term and long-term), and, if known, the likelihood of the outcomes for each affected class of persons by the relationship category.

Favorable non-economic outcomes:

B: The purpose of immunization requirements for school entry is to protect students, staff, and the visiting public against vaccine-preventable diseases within schools and broader communities. It is anticipated that these rule changes will lead to higher vaccination rates in schools and, subsequently, the surrounding community and result in decreases in vaccine-preventable disease. The Department expects the changes to the nonmedical exemption process to reduce the number of “convenience” exemptions claimed by parents who are not opposed to vaccination but who may simply lack the time or resources to take their child to a healthcare provider for the required immunizations.

Further, the Department expects the changes to the nonmedical exemption process and online education module will result in increased access to science-based, credible information for informed decision-making prior to parents claiming a nonmedical exemption.

C, CLG, B: The proposed changes to this rule will result in clarification for consistent interpretation by end-users of the rule, more consistent terminology and simplification of language, and better alignment with statute; all of which the Department expects will result in improved customer experience.

Unfavorable non-economic outcomes: N/A

3. The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues.

A. Anticipated CDPHE personal services, operating costs or other expenditures:

The Department identified minimal costs to implement the provisions of SB 20-163, as outlined in the Fiscal Note:

|Type of Expenditure |Year 1 |Year 2 |

|Update Online Education Module |

|Personnel costs |$5,714 |-- |

|Technology cost |$10,022 |$1,358 |

|Learning Management System license or renewal |$2,595 |$1,060 |

|Language services |$14,051 |$11,944 |

|Annual Alignment Evaluation* |

|Facilitation contractor for stakeholder meetings |$10,000 |$10,000 |

|Total |$42,382 |$24,362 |

*Note: This table contains total costs for the Department to implement SB 20-163, including components not specifically addressed in this proposed rule change. SB 20-163 requires the Department to annually evaluate the state's immunization practices, including a review of updated guidelines recommended by the Advisory Committee on Immunization Practices. When the Department plans to consider proposing the addition of new vaccines to Section II of this rule for school entry, the Department will hire an external facilitator to seek input from stakeholders. When the Department decides to maintain existing practice, the Department will submit a memo outlining our decision or offer to present this decision to the Board of Health.

Anticipated CDPHE Revenues: NA

B. Anticipated personal services, operating costs or other expenditures by another state agency: NA

Anticipated Revenues for another state agency: NA

4. A comparison of the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction.

Along with the costs and benefits discussed above, the proposed revisions:

___ Comply with a statutory mandate to promulgate rules.

XX Comply with federal or state statutory mandates, federal or state regulations, and department funding obligations.

___ Maintain alignment with other states or national standards.

___ Implement a Regulatory Efficiency Review (rule review) result

XX Improve public and environmental health practice.

XX Implement stakeholder feedback.

XX Advance the following CDPHE Strategic Plan priorities:

Goal 1, Implement public health and environmental priorities

Goal 2, Increase Efficiency, Effectiveness and Elegance

Goal 3, Improve Employee Engagement

Goal 4, Promote health equity and environmental justice

Goal 5, Prepare and respond to emerging issues, and

Comply with statutory mandates and funding obligations

Strategies to support these goals:

___ Substance Abuse (Goal 1)

___ Mental Health (Goal 1, 2, 3 and 4)

___ Obesity (Goal 1)

XX Immunization (Goal 1)

___ Air Quality (Goal 1)

___ Water Quality (Goal 1)

XX Data collection and dissemination (Goal 1, 2, 3, 4, 5)

___ Implement quality improvement/a quality improvement project (Goal 1, 2, 3, 5)

___ Employee Engagement (Goal 1, 2, 3)

___ Decisions incorporate health equity and environmental justice (Goal 1, 3, 4)

___ Detect, prepare and respond to emerging issues (Goal 1, 2, 3, 4, 5)

XX Advance CDPHE Division-level strategic priorities.

● Increase the percentage of kindergartners protected against measles, mumps and rubella (MMR) from 91.1% to 92% (620 more kids) by June 30, 2021 and increase to 95% by June 30, 2024.

The costs and benefits of the proposed rule will not be incurred if inaction was chosen.

Costs and benefits of inaction not previously discussed include: N/A

5. A determination of whether there are less costly methods or less intrusive methods for

achieving the purpose of the proposed rule.

Rulemaking is proposed when it is the least costly method or the only statutorily allowable method for achieving the purpose of the statute. For this rule, both apply. As there is no anticipated cost of compliance with the proposed amendments to the rule, there is no less costly method to achieving the purpose of the rule. Additionally, the Board of Health is required by section 25-4-904, C.R.S. to “establish rules and regulations for administering this part 9.” Furthermore, the proposed amendments should strengthen the department’s partnership with community stakeholders in schools, childcares and colleges and universities as the proposed amendments clarify or simplify existing requirements, or align requirements with statute.

6. Alternative Rules or Alternatives to Rulemaking Considered and Why Rejected.

The only alternative considered was to leave the rule as adopted. This was rejected because SB 20-163 passed the legislature and was signed into law by the Governor. This new legislation codified several new requirements affecting school entry immunizations; thus, this rule must be amended to be brought back into alignment with statute.

7. To the extent practicable, a quantification of the data used in the analysis; the analysis

must take into account both short-term and long-term consequences.

The Department anticipates these rule changes will lead to higher vaccination rates in schools and, subsequently, the surrounding community and result in decreases in vaccine-preventable disease. In 2019, the Department, in conjunction with the Governor’s Office, set a goal to reverse the downward trend and increase the percent of kindergartners protected against MMR from 87.4% to 90% (1,669 more kids) by June 30, 2020. The Department exceeded its one-year goal to have 90% of kindergartners vaccinated for MMR with 2,289 more children vaccinated over the last school year, bringing the state’s kindergarten MMR rate for the 2019-2020 school year to 91% -- a 3.7% increase.[1] While this is very positive progress, this rate is still below the 92 - 94%[2] community immunity threshold needed for protection against measles.

The gains observed in the 2019-2020 school year reflect a single point-in-time (October 2019 - January 2020), prior to when the COVID-19 pandemic really began in Colorado. Between January 5 and March 14, there was a 7.3% increase in pediatric and adolescent doses administered in the Colorado Immunization Information System (CIIS) when compared to the previous year. Since then, there has been a 9.9% decline in doses reported as administered across all pediatric and adolescent vaccines in CIIS from March 15, 2020 through October 24, 2020.

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This decline is concerning when we consider annual hospitalizations and emergency department (ED) visits for children 0 - 18. Per a March 2020 report from Children’s Hospital Colorado[3], there were 524 hospitalizations and over 10,000 ED visits among Colorado children in 2018 due to vaccine-preventable diseases. Similar to prior years, influenza, pneumococcal disease and pertussis were the three most common reasons for hospitalization due to vaccine-preventable disease in Colorado children in 2018; whereas influenza, varicella, and pertussis were the three most common reasons for ED visits. Total hospital charges and ED charges for vaccine-preventable diseases were over $59 million, with over $49 million due to influenza alone. The second most common vaccine-preventable cause of hospitalization was pneumococcal disease, with 51 hospitalizations and total hospital/ED charges of $8.5 million.

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[1]2019-2020 School And Childcare Immunization Database,

[2] Orenstein W., Seib, K. Mounting a Good Offense against Measles. N Engl J Med 2014; 371:1661-1663

[3] Cataldi, JD, et al. The Vaccine-Preventable Diseases Report Volume XVI, Number 1. March 2020.

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